Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|June 2, 2010
- Pharmaceutical Technology-06-02-2010
- Volume 34
- Issue 6
Pharmaceutical Technology, June 2010 Issue (PDF)
Excipients Step into the Spotlight
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Articles in this issue
over 16 years ago
Anniversary Seasonover 16 years ago
Outsourcing Clinical Trial Development and Materialsover 16 years ago
Leveling the Compliance Playing Fieldover 16 years ago
Excipients Step into the Spotlightover 16 years ago
EU Debt Crisis Adds Uncertaintyover 16 years ago
Puerto Rico Builds a Foundation for Biopharmaceuticalsover 16 years ago
Even Packaging Can Multitaskover 16 years ago
Securing the Supply Chainover 16 years ago
A Q&A with Uwe Ross of Binderover 16 years ago
Making a DifferenceAdvertisement
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FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.
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